Apparatus and method for self-administration of optical scanning of a person&#39;s eye optical system

ABSTRACT

A system for obtaining optical coherence tomography of the optical system of a person, comprising: an eyepiece customized for alignment and positioning to contact a person&#39;s eye socket and having a lens pocket for receiving a refractive lens customized for the person&#39;s eye refraction characteristics; a condensing system for receiving light from the eyepiece; a scanning module optically connected to the condensing system and having a mirror tiltable in two directions for obtaining optical scanning data from the person&#39;s optical system; and a spectrometer and camera module optically connected to the scanning module for obtaining and storing the optical scanning data, wherein the eyepiece, condensing system and scanning module are arranged to provide an optical path for delivering a light beam to the person&#39;s eye, and receive reflected light to be directed to the scanning module.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Ser. No. 62/579,599, filed Oct.31, 2017, which is incorporated by reference herein.

TECHNICAL FIELD

The present invention relates to an apparatus and method for a patientuser to obtain optical scanning data of his eye optical system withoutan eye care professional.

BACKGROUND OF THE INVENTION

Optical Coherence Tomography (OCT) has become a standard of care in eyecare practices for a variety of disorders that manifest in the retina.These devices range in price from $30,000 to $90,000 and typicallyrequire a skilled operator to obtain the desired results. More recentlythere are OCT devices that have the ability to automatically align to apatient's eye and to focus, but still require operator input and patientpositioning. While these devices are now found in many eye carepractices, they still require patients to visit the office for initialdiagnosis and monitoring of disease progression. Patients are often sentaway for months at a time, and occasionally have sudden changes invision. These situations are potentially avoidable if there was greateraccess to devices, they were loser cost, and did not require and eyecare professional operator to obtain scans.

SUMMARY OF THE INVENTION

The present invention solves this problem in multiple ways. First, theinvention provides for significantly lower cost of goods utilizing anovel optical design that is customized to the patient. Presets for thedevice allow the device to be customized for the patient's eyerefraction. In one embodiment their glasses prescription is utilized tomanufacture a custom lens mounted in the eyepiece of the system for eachof the patient's eyes. This aspect allows for a novel optical design andelimination of several moving parts that would normally be found inthese other commercial devices that must accommodate a broad range ofpatient eye variance and facial topography composition. The primary usecase that is contemplated is home use, whereby patients are able toself-align using a novel eyecup interface that contains a lens with thepatient's refraction, mounted within the eyecup. Additional use casesinclude settings where a skilled operator and/or clinician may not bepresent. One example is a retail pharmacy clinic location, or embeddingtechnology in a kiosk. The contours of the eyecup are novel with respectto protruding aspects that hold lids open and position to the orbit in arepeatable fashion. In the home use scenario, scans are performedwithout an operator and automatically uploaded to the cloud where imageprocessing is performed to optimize scan quality, and layers segmented,measurements made, and measurements, data, and reports generated forreview by an eye care or other medical professional. In one embodimentthere is a subsystem that allows select measurements to be tracked overtime in a dashboard view so as to track changes in measurements (likecentral retinal thickness, as one example). The eyecup may be disposable(single patient use) but can also be for repeated use, and cleanedbetween uses, and can include features that set machine information(such as the coherence position in OCT). In another embodiment theeyecup could be utilized in other ophthalmic measurement and imagingdevices.

In summary, the invention solves the problem of ease-of use forperforming OCT measurements, for the prevention of vision loss betweenvisits by having a low cost of goods thereby enabling potential rentalof device. Cost reduction is achieved with multiple novel elements to befurther described. Additionally, the cloud-based analysis aspect allowsfor a physicians to be immediately notified when there is a change thatthey wish to track and detect, and notify a patient to return to thepractice for further evaluation and potential treatment.

While home use is the primary anticipated use case, in anotherembodiment the device could be located in other locations convenient topatients. In another embodiment the device could be mounted in a retailpharmacy kiosk or other kiosk that is utilized to collect biometric andother health information.

The invention differs from other inventions via the novel eyecup, noveleyecup containing lens customized to the patient, thereby allowingmultiple moving parts to be eliminated and significant cost reductionand ease-of-use. This would allow a single hardware implementation ofthe device where all parameters are set using the customized eyecup. Thecustomized eyecup and lens would allow correction of spherical andastigmatism errors either difficult or impossible with typicalophthalmic instruments and allow correction of higher order aberrationsthat are usually impossible with ophthalmic imaging instruments. Theinvention differs in light source and calibration method that allows forutilization of lower cost light source. The novelty of the use of arelatively inexpensive source and simple interferometer is not dependenton the eyecup or lens and could be used with any OCT system.

Primary improvements of the invention over other OCT devices aredescribed above.

The process steps of using the invention may be as follows:

-   -   It is determined by the eye care professional that the diagnosis        for a given patient warrants continuous home monitoring between        visits so as to detect changes that may be occurring prior to        loss of vision. One example use case would be tracking central        retinal thickness over time as an early warning system.    -   The next step of the process is to obtain the patient's        refraction and/or measure their glasses in a commercially        available lens meter (per eye). This could also be achieved via        tests more complex than an ‘eye exam’ or autorefractor        measurement, (such as specialized OCT measurement of cornea and        lens shapes and thicknesses), to give a more accurate        measurement of optical correction needed to give the best        possible retinal imaging.    -   Patients would then be tested with a test device to determine        any other settings that need to be optimized for their given        device, per eye.    -   Patients would be taught how to self-position on a device and        would have several test measurements.    -   A customized eyecup would be manufactured per the patient's        refraction (per eye). Said customized eyecup would contain the        manufactured lens that matches their prescription.    -   A device would be shipped to their home along with the        customized eyecup(s).    -   The device would be connected to home wifi or cellular internet        for transmission of data.    -   Patients would self administer a test of obtain their OCT scan        data.    -   Data would be automatically uploaded over the internet to the        cloud for image processing, layer segmentation, analysis and        reporting of results to an eye care professional.    -   Eye care professional would have a dashboard that displays        results with color coding on those that are at risk per settings        and thresholds of his choice.    -   Settings on the clinical viewer would be fully customizable in        measurement views, analysis, thresholds for events, and        automated contact of patient to come back to the office of the        eye care professional for a visit (and other action items and        messages for the patient that may or may not involve an office        visit).

While the device could potentially be used to manage disease, theinitial intended use for regulatory purposes it to be an early warningsystem to return for a visit to the office of the eye care professional,ahead of a regularly scheduled visit so as to prevent vision loss.

Uses of the invention would be for all diseases and disorders thatmanifest in the retina, not necessarily just retinal disease. In oneembodiment the device could be used to monitor neurodegenerativediseases. The ways that the invention achieves the desired result isthrough its novel design that allows for both cost reduction, ease ofuse, self-administration, and automatically generated results.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1A is a block diagram of two eyes and two eyecups forming part ofthe invention.

FIG. 1B is a block diagram of an eye, eyecup including refractivecompensating element for the eye imaged, scanned beam condensing systemMEMs (microelectro mechanical system) (or galvoscanner) and retroreflector, with beam traces in dotted lines.

FIG. 1C is an alternative arrangement of FIG. 1B, with a dichroic mirroradded.

FIG. 2A is an alternative arrangement of FIG. 1B, having an adjustablelength arm, where the optical path for one eye is longer, the arm lengthbeing customized for the eye being examined, the length determining theposition of the retroreflector in the system. The length can be set bythe rotation of a circular part that is inclined.

FIG. 2B is another alternative arrangement of FIG. 1B, like FIG. 2A, butwhere the optical path for the other eye is longer.

FIG. 2C shows a circular part usable in the embodiments of FIGS. 2A and2B to adjust the length by rotating the circular part having an inclinedface.

FIG. 3 is block diagram of a similar system of FIGS. 1A, 1B, 1C, 2A, 2Band 2C, wherein the eyecup contains indicia to indicate whether it isdesigned for the left eye or right eye. The relay lens of the condensinglens system contains a sensor to detect the indicia to know which sidedeyecup is present. The sensor could be a mechanical switch in the relaylens system acted on by a protrusion on the eyecup.

FIG. 4 shows an eyecup which contains a slot for receiving the user'seyeglasses or spectacles instead of having an embedded refractivecompensating element, and the eyecup still provides a way to contactbetween the eye socket and the system to have the correct path length,with the user's eyeglasses providing the refractive correction.

FIG. 5 is a block diagram showing a spectrometer and camera module,processing and uploading module and a communications network fortransmitting the imaging data to a remote location such as the cloud forprocessing and access by an eye care professional. The eyecup shown isfor a right eye and has a profile which extends around the side of aperson's face to help in fitting and also identify the eyecup as a righteyecup. The left eyecup would be the mirror image of the right eyecup.

FIG. 6A shows in block form an eye, eyecup, and handheld or portableimaging system, wherein the eyecup abuts the eye and imaging system andsets the correct refraction and optical path length between the eye andimaging system so that the retina is at the correct distance from thesystem for the person. This is important for coherence based imagingtechniques like OCT. This arrangement simplifies the operation anddesign of the imaging system and will reduce cost and complexity. Inthis Figure, the length of the eyecup for the left eye is longer thanthe length of the eyecup for the right eye.

FIG. 6B shows a system like that in FIG. 6A, except that the length ofthe eyecup for the left eye is shorter than the length of the eyecup forthe right eye. In each of the FIGS. 6A and 6B, the length of the eyecupis set based on the optical system of the person's eye.

FIGS. 7A and 7B show in block from a system which contains a wide-anglerelay lens system, wherein the eyecup contains, in addition to arefractive corrective lens, a lens system which increases the angle ofview inside the eye.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A preferred embodiment will be described, but the invention will not belimited to this embodiment.

The invention provides an eyepiece for use in a system for obtainingdata of the optical system of a person, comprising an eyepiececustomized to contact and tightly fit in a person's eye socket andhaving a lens pocket for receiving a refractive lens customized for theperson's eye refraction characteristics.

The eyepiece may further include a condensing system for receiving lightfrom the eyepiece, a scanning module optically connected to thecondensing system and having a mirror tiltable in two directions forobtaining optical scanning data from the person's optical system, animaging system optically connected to the scanning module for obtainingand storing the optical scanning data, wherein the eyepiece, condensingsystem and scanning module are arranged to provide an optical path fordelivering a light beam to the person's eye, and receive reflected lightto be directed to the scanning module.

The eyepiece may further include a communication link for communicatingthe optical scanning data to a remote location for processing. Theeyepiece and lens may be customized for any astigmatism and aberrationsof the person, and may be customized for eye length of the person.

The eyepiece may include a right and left eyepiece for each of the rightand left eyes of the person. The eyepiece may have right and leftdetachable eyecups each with an index and adapted to mate with arespective right and left eyepiece body to provide mating of the correctright or left eyecups with the respective eyepiece body.

The eyepiece lens pocket may be adapted to receive a lens of theperson's prescription eyeglasses, or to contain a customized refractivelens for the person's eye.

The eyepiece may include an imaging beam generator which is adapted totransmit an imaging beam through the eyepiece, whereby the person's eyereflects a light beam back to the scanning module. The imaging beamgenerator may produce an infrared optical imaging beam.

The position between where the eyepiece contacts to the person's eyesocket and the scanning module may be adjustable in length to adapt tothe person's focusing eye length. The eyepiece may have a protrusionadapted to hold a person's eyelids open and position the eyepiece to theperson's orbit.

The communication link may comprise the internet for communicating theoptical scanning data to the cloud for image processing, analysis andaccess by an eye care professional.

The scanning module may be a MEMs scanning module. The eyepiece mayfurther include a grid for a person to input any changes in vision. Thegrid may be an Amsler grid or Yannuzzi grid.

The eyepiece lens may be a variable lens or a phoropter trial lens set.

The eyepiece may contain an RFID chip to uniquely identify the personfor whom the eyepiece is customized, and parameters for customization.

The eyepiece may include at least one filter. The eyepiece may include alens optimized for imaging different areas of the retina of the person.The eyepiece may include a fundus imaging device, an eye measurementdevice, or an eyecup for performing a dry eye test. The eyepiece mayinclude a customized eyecup having an electrical sensor for performingmultifocal electrophysiology exams. The eyepiece may include a lightsource to illuminate an eye. The eyepiece may include an eyecup having aside which extends further to contact the side of a person's face. Theeyepiece may include a wide-field imaging lens. The eyepiece may includea feedback loop to auto-capture imaging data of the eye. The eyepiecemay be used in a system for obtaining optical coherence tomography.

The invention provides a system for obtaining data of the optical systemof a person, comprising an eyepiece customized to contact and tightlyfit in a person's eye socket and having a lens pocket for receiving arefractive lens customized for the person's eye refractioncharacteristics, a condensing system for receiving light from theeyepiece, a scanning module optically connected to the condensing systemand having a mirror tiltable in two directions for obtaining opticalscanning data from the person's optical system; and an imaging systemoptically connected to the scanning module for obtaining and storing theoptical scanning data, wherein the eyepiece, condensing system andscanning module are arranged to provide an optical path for delivering alight beam to the person's eye, and receive reflected light to bedirected to the scanning module.

According to a preferred embodiment of the invention, FIG. 1 shows aneyecup module, containing novel design and elements that allow lids tobe held open, while positioning to the ocular orbit, allowing repeatablepositioning. The eyecup module also contains a lens, or multiple lensesthat allow for customization to the patient's refraction includingastigmatism and other aberrations. The eyecup also contains distance andother positioning settings so as to customize to a given patient'srefraction.

Another part of the device is the micro electromechanical system (MEMS)scanning module. The module uses a single mirror that tilts in twodirections (XY scanning) and allows for a more optimized opticalarrangement. E.g. galvo scanners are typically made up of separate X andY scanners. The novel combination with eyecup and other elements allowsscanning of diverse patterns and regions, minimizing opticalaberrations.

Another part of the device is the spectrometer and camera module. Thenovel combination with other elements allows for cost reduction and highquality. The broadband source and spectrometer of the proposed OCTsystem could be achieved with a swept source and receiver electronicswith the required characteristics.

Another part of the device is the localized processing and uploadingmodule for uploading images and data over the internet to the cloud.Processing could be completed in the cloud. In fact each scanning unitcould be identical in hardware and software (eyecup containscustomization) with all calibration files needed for processing beingstored in the cloud.

Another part of the device is a grid (Amsler Grid, Yannuzzi Grid orother) that allows the user to also indicate via switch or audio voicedetection that they have other changes due to metamorphopsia or otheraspects that may cause a change in vision.

In an alternative embodiment, the device is a combination device thatperforms OCT as described, and also contains an Amsler Grid, contrastsensitivity, visual field, microperimetry or other functional visionassessment.

In an alternative embodiment the eyecup does not have a lens insertedbut the customization is achieved in the device itself.

In an alternative embodiment a liquid lens or other variable lens setupis employed so as to customize to the patient's refraction.

In an alternative embodiment, a lens from a phoropter trial lens set isutilized to customize the patient's refraction.

In an alternative embodiment ophthalmic tests that typically takeseveral minutes are performed over many days/months/years in severalparts.

In an alternative embodiment, due to the novel optical design, the MEMScan be positioned in differing locations so as to optimize scan, field,target and viewing for other ancillary vision tests.

In an alternative embodiment the individual lens customization allowsfor post processing to be customized on an individual eye basis.

In an alternative embodiment, the coherence position is set per a pin orlever that is adjustable to varying lengths to create ideal position.This can be accomplished via a sliding mechanism, screw mechanism, or anangular surface that adjusts position to a keyed setting per eye whentwisted. This keyed position per eye allows the device to know when eachparticular eye is being imaged. In another embodiment and optical switchis used to detect the right eye (OD) or left eye (OS) and know that theeye is properly positioned.

In an alternative embodiment an OCT feedback loop would determineoptimal positioning and trigger scan capture and/or flag for presence ofdata and quality of data.

In an alternative embodiment an RFID chip is inserted into the eyecup toinform on test subject identification and parameters for deviceadjustment, and which eye is being imaged.

In an alternative embodiment, the MEMS allows for display of differentpatterns utilized in other vision and functional tests including but nonlimited to grids, Amsler Grid, Yannuzzi Grid, Adaptive Grids, contrastsensitivity, frequency doubled technology (FDT), visual acuity,perimetry, and micro-perimetry.

In an alternative embodiment, the device allows for an eyecup andoptical channel for traditional (not OCT based) fundus imaging ofvarious modalities.

In an alternative embodiment, the device allows for an eyecup andoptical channel for traditional and other (not OCT based) ocularmeasurements of various modalities.

In an alternative embodiment spectral filters, single multiple,continuous can be mounted in the device and/or eyecup.

In an alternative embodiment one could modulate the super luminescentdiode (SLD).

In an alternative embodiment, one could perform an eye tracking test formultiple disorders.

In an alternative embodiment one could incorporate a camera to performpupilometry.

In an alternative embodiment one could incorporate lens autofluorescenceand OCT technology for assessment of aggregated glycation end productsfor state of diabetes, and/or implied blood glucose/hemoglobin A1clevels.

In an alternative embodiment the eyecup is adaptable to multiple eyedevices that allows for individual optimization per eye built into theeyecup and to add attenuation to the eyecup, and different filters onthe eyecup.

In an alternative embodiment different sectors of the customized lensare optimized for imaging different areas of the retina. This could beachieved with a single optical element with the required shape, compoundelement or multi element assembly.

In an alternative embodiment, the eyepiece technology, includingcustomized refraction per eye is incorporated into a device fortraditional fundus imaging and wide field fundus imaging, therebyachieving decreased aberrations and better image quality in the centralfield and the periphery.

In an alternative embodiment the eyecup can be adapted for use on anyeye imaging device to improve image quality including but not limited tofundus camera, OCT, slit lamp imaging device, smartphone imagingdevices, widefield imaging devices (all in various modalities—color,OCT, red free, autofluorescence, fluorescein angiography, ICGangiography, hyperspectral, and multi-spectral imaging).

In an alternate embodiment the eyecup contains a lens system that allowsfor position of optical components close to the cornea to facilitatewide-field imaging

In an alternative embodiment, the device with customized eyecup isutilized for a dry eye test.

In an alternative embodiment, the device is utilized for anteriorsegment and microscope mounted eye imaging applications.

In an alternative embodiment, the customized eyecup is used with onophthalmic stimulus and/or imaging device for parts of a longer testconducted over several days. In this manner a longer test can beconducted in small portions over several consecutive days. This wouldmean that a test such as a visual ‘perimetry test’ or another previouslydescribed visual function test could be obtained in a ‘distributedmanner’.

In an alternative embodiment the customized eyecup contains anelectrical sensor to perform multifocal electrophysiology exams.

In an alternative embodiment achievable source is used in the OCT systemwith a coherence length long enough so that no adjustments of coherenceposition is needed.

In an alternative embodiment a spectrometer design is used in the OCTsystem such that the imaging range is sufficient so that no adjustmentsof coherence position is needed.

In an alternative embodiment the optical beam waist at the cornea issufficiently small so that no refractive element is needed.

In an alternative embodiment the eyecup with lens is customized to thepatient is adapted to an existing or new device and optimized for use inother eye imaging devices (fundus cameras, Optos, OCT, etc.). This willcorrect aberrations specific to the patient.

In an alternative embodiment, illumination with a light source is builtinto the eyecup so as to illuminate trans-sceral for purposes of retinalimaging.

In an alternative embodiment, a wide field lens is fitted in the eyecupand then examined and/or imaged with an opthalmoscope, indirectophthalmoscope, slit lamp, or other ophthalmic device.

In an alternative embodiment the eyecup is used to optimize positioningany handheld ophthalmic imaging and/or measurement device.

In an alternative embodiment the patient's own eyeglasses or spectaclesare utilized in the optical train to correct for their own specificrefraction and astigmatism.

In an alternative embodiment a wide field lens is mounted in the eyecupand either coupled or de-coupled from a retinal examination instrument(indirect or direct ophthalmoscope, slit lamp, smartphone-based imagingdevice) to image the retina.

The device may be used in a home environment, self-administered.

The device may be incorporated into a kiosk (like those found in retailpharmacies) for self-administration of test.

The device may be utilized in any setting where a skilled operator ormedical professional is not present

While a preferred embodiment with alternatives has been described, theinvention is not limited to these embodiments, and its scope is definedonly by way of the claims.

The invention claimed is:
 1. An eyepiece for use in a system forobtaining data of the optical system of a person, comprising: aneyepiece customized to contact and tightly fit in a person's eye socket,wherein the eyepiece abuts the person's eye socket and an imaging systemand sets the correct refraction and optical path length between theperson's eye and imaging system so that the retina is at the correctdistance from the imaging system for the person, and having a lenspocket having a refractive lens manufactured to be customized to matchthe person's eye refraction characteristics.
 2. The eyepiece of claim 1,further including a condensing system for receiving light from theeyepiece.
 3. The eyepiece of claim 2, including an imaging beamgenerator which is adapted to transmit an imaging beam through theeyepiece, whereby the person's eye reflects a light beam back to thescanning module.
 4. The eyepiece of claim 3, wherein the imaging beamgenerator produces an infrared optical imaging beam.
 5. The eyepiece ofclaim 1, wherein the eyepiece and lens is customized for any astigmatismand aberrations of the person.
 6. The eyepiece of claim 1, including aright and left eyepiece for each of the right and left eyes of theperson.
 7. The eyepiece of claim 1, wherein the eyepiece comprises rightand left detachable eyecups each with an index and adapted to mate witha respective right and left eyepiece body to provide mating of thecorrect right or left eyecups with the respective eyepiece body.
 8. Theeyepiece of claim 1, further including a MEMs scanning module.
 9. Theeyepiece of claim 1, wherein the lens is a variable lens.
 10. Theeyepiece of claim 1, wherein the lens is a phoropter trial lens set. 11.The eyepiece of claim 1, wherein the eyepiece contains an RFID chip touniquely identify the person for whom the eyepiece is customized, andparameters for customization.
 12. The eyepiece of claim 1, wherein theeyepiece includes at least one filter.
 13. The eyepiece of claim 1,wherein the eyepiece includes a lens optimized for imaging differentareas of the retina of the person.
 14. The eyepiece of claim 1,including a fundus imaging device.
 15. The eyepiece of claim 1,including an eye measurement device.
 16. The eyepiece of claim 1,wherein the eyepiece includes an eyecup for performing a dry eye test.17. The eyepiece of claim 1, wherein the eyepiece includes a customizedeyecup having an electrical sensor for performing multifocalelectrophysiology exams.
 18. The eyepiece of claim 1, wherein theeyepiece includes a light source to illuminate an eye.
 19. An eyepiecefor use in a system for obtaining data of the optical system of aperson, comprising: an eyepiece customized to contact and tightly fillin a person's eye socket and having a refractive lens manufactured to becustomized to match a person's eye refraction characteristics, whereinthe eyepiece abuts the person's eye socket and an imaging system andsets the correct refraction and optical path length between the person'seye and imaging system so that the retina is at the correct distancefrom the imaging system for the person; a condensing system forreceiving light from the refractive lens and condensing the light; amirror for receiving condensed light from the condensing system; aretroreflector for receiving light from the mirror; and an adjustablearm connected to the eyepiece and retroreflector for adjusting theposition of the retroreflector relative to the eyepiece.
 20. Theeyepiece of claim 19, including a right and left eyepiece for each ofthe right and left eyes of the person.
 21. The eyepiece of claim 19,wherein the eyepiece comprises right and left detachable eyecups eachwith an index and adapted to mate with a respective right and lefteyepiece body to provide mating of the correct right or left eyecupswith the respective eyepiece body.
 22. The eyepiece of claim 19, whereinthe lens is a variable lens.
 23. The eyepiece of claim 19, wherein thelens is a phoropter trial lens set.
 24. The eyepiece of claim 19,wherein the eyepiece contains an RFID chip to uniquely identify theperson for whom the eyepiece is customized, and parameters forcustomization.
 25. The eyepiece of claim 19, wherein the eyepieceincludes at least one filter.
 26. The eyepiece of claim 19, wherein theeyepiece includes a lens optimized for imaging different areas of theretina of the person.
 27. The eyepiece of claim 19, including a fundusimaging device.
 28. The eyepiece of claim 19, including an eyemeasurement device.
 29. The eyepiece of claim 19, wherein the eyepieceincludes an eyecup for performing a dry eye test.
 30. The eyepiece ofclaim 19, wherein the eyepiece includes a customized eyecup having anelectrical sensor for performing multifocal electrophysiology exams. 31.The eyepiece of claim 19, wherein the eyepiece includes a light sourceto illuminate an eye.